Status:

RECRUITING

Physical Activity and Community EmPOWERment Project

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Intellectual Disability

Neurodevelopmental Disorders

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzhe...

Detailed Description

Each potential adult with ID or family who contacts the research team will be called and screened for eligibility in the study. To determine eligibility, screening questions will include asking if the...

Eligibility Criteria

Inclusion criteria for adults with ID will include:

  • ages 18 and older with a prior clinical diagnosis of ID, confirmed by scores < 70 and + 90% on the Leiter-3 International Performance Scales and/or an adaptive behavior measure using the Vineland Adaptive Behavior Scales,
  • Medical clearance to participate in moderate-to-vigorous physical activity as determined by the American College of Sports Medicine (ACSM) preparticipation algorithm,
  • Adult does not show clinically elevated symptoms of Alzheimer's Disease (AD)/ Alzheimer's Disease and Related Dementias (ADRD) as indicated by a score of < 20 on the Dementia Screening Questionnaire for Individuals with Intellectual Disabilities.
  • One caregiver/guardian is able and willing to participate.
  • must tolerate at least 8 hours of daily wear-time of Actigraph device during initial assessment period (4 of 7 days),
  • must average 20 minutes or less of moderate to vigorous physical activity (MVPA) minutes per day (140 MVPA minutes or less across 7-day period measured during the initial assessment period, and
  • must reside in North Carolina or Arkansas.

Exclusion Criteria for adults with ID:

• Diagnosis of AD, dementia, or related disorders. Participants will not be excluded based on gender, race, or ethnicity. There will be no upper age limit due to the heterogeneity of onset of AD/ADRD in individuals with ID.

Inclusion criteria for coach will include:

  • access to the internet and a mobile device,
  • has weekly contact with the adult participant with ID,
  • can converse and read in English to comprehend intervention materials and website content, and
  • must reside in North Carolina or Arkansas

Inclusion criteria for caregiver will include:

  • ability to converse and read in English to comprehend and answer interview questions, (2) must care for an adult with ID who is willing to participate in the study,
  • must reside in North Carolina or Arkansas, and
  • must attend all study visits with adult with ID.

Key Trial Info

Start Date :

January 10 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2028

Estimated Enrollment :

376 Patients enrolled

Trial Details

Trial ID

NCT06740162

Start Date

January 10 2025

End Date

June 1 2028

Last Update

February 23 2026

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Arkansas

Fayetteville, Arkansas, United States, 72701

2

University of North Carolina

Chapel Hill, North Carolina, United States, 27517